Regulatory Business/Technical Analyst - SSP

BA / TA Role Expectations:

This role is to perform Business Analyst/Technical Analysis for a Regulatory Domain data hub. The hub ingests data from multiple regulatory source systems, and then maps and publishes the data into key system agnostic regulatory data publications.

• One goal of the hub is to replace existing point-to-point (source to consumer) integrations with consumption via the standard data publications.
• Another goal is to support EMA IDMP requirements in 2022+

• Deliverables and Key Skills:
  • KEY: Pharma Regulatory Affairs domain experience.
  • KEY: Strong Client facing, critical thinking and self-directed.
  • KEY: Ability to interface with IT and Business Stakeholders to discuss solving data needs. 1) Need to be able to interpret and need and guide requestors as to how to get to that data. 2) Need to determine if data need is not met, approach to address the need.
  • KEY: Evaluate all Regulatory Affairs existing point-to-point integrations and understand data fields involved in such integrations. Build heat maps of common fields, i.e., those that are used across multiple integrations. Finally, understand how to replace such integrations via the new hub publications, at the data level.
  • Work independently with requestors to define data needs under direction of account manager, scrum master, and project manager
  • Able to extract and provide data on an as needed basis to help IT and business understand data
  • Serves as the conduit, explaining requested data needs to the software development team
  • Able to take a data request through a process that will determine 1) if the requested data already exists, and if so, where can it be found or 2) if the data does not exist, where should it come from (source system) 3) are there special means to getting the field 4) how to best add/change it
  • Critically evaluate data requirement needs gathered from multiple sources, reconcile conflicts, decompose high-level requests into data details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true data needs.
  • Document the information gathered and analyzed into a detailed data model(s) that is easily understandable and digestible by both technical audience and business leads
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts.
  • Experienced in Software Development Lifecycle (SDLC) for IT solution implementation
  • Proactively communicate and collaborate with the business to analyze data requests deliver artifacts as needed, such as Business Requirements Documents and Use Cases, starting with standard templates.
• Preferred Skills:
  • Experience with large integrated data sets
  • Mid-level SQL Query skills as much of the role is determining how to get to the right data in various source systems
  • Experience with various SQL Querying tools, i.e., Athena.
  • AWS experience
  • Agile/Scrum experience

The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.